FDA Issues Safety Warning For Heater-Cooler Devices

The U.S. Food and Drug Administration (FDA) has issued a safety warning concerning infections caused by nontuberculous mycobacteria (NTM) organisms found in water, which can grow in water tanks of heater-cooler devices in operating rooms. According to the FDA, “Contaminated water from the heater-cooler device has the potential to aerosolize into the operating room during surgery, and this may lead to infection primarily in cardiovascular patients undergoing open-chest surgical procedures.”

The FDA recommends that health care professionals and facilities perform appropriate maintenance on such devices to reduce the risk of infection. For more information on heater-cooler -devices, visit the FDA’s website

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: Biological Processes, Nontuberculous Mycobacteria, Operating Rooms, Cardiac Surgical Procedures

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